MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190713

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2024

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility's biomedical technician (bmt) reported that during set up, a 2008t hemodialysis machine displayed a ¿24v low¿ message.The machine was pulled and the bmt found that the brown wire from the distribution board to the power supply was burned.There was no burning smell, melting, smoke, spark, or flame.The wire is the original fresenius part on the machine.The machine has not had any past problems with failing the electrical leakage test or any other damaged component associated with the burnt wire.The bmt stated that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt replaced the wiring from the distribution board to the power supply to resolve the issue and the machine is back in service without reoccurrence of the reported event.There was no harm to any patients or individuals because of this malfunction.Additionally, the bmt confirmed that the complaint device is available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Additional information: b5, d9, h3 plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).The manufacturer was able to determine a causal relationship between the objective evidence provided by the customer and the reported event.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The reported event has been confirmed.

Event Description

A user facility's biomedical technician (bmt) reported that during set up, a 2008t hemodialysis machine displayed a ¿24v low¿ message.The machine was pulled and the bmt found that the brown wire from the distribution board to the power supply was burned.There was no burning smell, melting, smoke, spark, or flame.The wire is the original fresenius part on the machine.The machine has not had any past problems with failing the electrical leakage test or any other damaged component associated with the burnt wire.The bmt stated that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt replaced the wiring from the distribution board to the power supply to resolve the issue and the machine is back in service without reoccurrence of the reported event.There was no harm to any patients or individuals because of this malfunction.The complaint device was not returned to the manufacturer for physical evaluation.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 19146713
• MDR Text Key: 340629689
• Report Number: 0002937457-2024-00655
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 05/28/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1